Plain English Summary

Background and study aims Cytokine-induced killer cells or CIK cells are a type of immune system cell that can be grown from a patient’s own cells in the lab and then given back to the patient to kill cancer cells. CIK treatment could be used to treat patients with leukemia (cancer of the white blood cells). The aim of this study is to find out whether CIK treatment improves the disease outcome of leukemia patients and reduces the number of chemotherapy cycles required.

Who can participate? Patients aged between 5 and 60 with leukemia

What does the study involve? Participants are treated with either standard chemotherapy or chemotherapy combined with CIK treatment. Their clinical outcome is closely monitored with prompt supportive treatment and relapse prevention treatment. Whole body PET/CT scans are used to monitor disease development. At the end of the study, the relapse-free period and overall survival rates are compared among different age groups, leukemia types and treatment strategies.

What are the possible benefits and risks of participating? This study should help to improve the well-being of leukemia patients in China. Immediate direct benefits are expected to be observed with CIK treatment. The side effects of chemotherapy would be reduced with the use of CIK treatment. The long-term tumor-killing effects of CIK cells remain unknown and are likely to be vary by person. The main risk of giving CIK cells to leukemia patients is infection from contamination of cultured blood products. Therefore, good manufacturing practice conditions are strictly followed. Participants are closely monitored during treatment.

Where is the study run from? First Affiliated Hospital of Harbin Medical University (China)

When is the study starting and how long is it expected to run for? January 2011 to December 2017

Who is funding the study? 1. National Natural Science Foundation (China)2. 863-Program in the "Eleventh Five" (China)3. Science and Technology Platform in Heilongjiang (China)